Identity
- Trade Name
- SapphirePlus Infusion Kit - US FDA UDI
- Generic Name
- Bedside infusion pump, single-channel FDA UDI
- Model / Reference
- 17000-033-0001 FDA UDI
Identifiers
- Catalog Number
- 17000-033-0001 FDA UDI
- Primary DI / UDI-DI
- 17290109150229 FDA UDI
- 510(k) Number
- K141389 FDA UDI
- FDA Product Code
- FRN FDA UDI
- GMDN Term
- Bedside infusion pump, single-channel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Bedside infusion pump, single-channel
SapphirePlus Infusion Kit - US by Eitan Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bedside infusion pump, single-channel.
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Cleared under the same submission
K141389 also covers:
- AAP402-01 - MICROBORE YELLOW MARKED WITH NON-VENTED SPIKE — EITAN MEDICAL LTD
- AP206-01 INFUSION SET WITH NON-VENTED SPIKE, 1.2 FILTER AND NEEDELESS Y-SITE — EITAN MEDICAL LTD
- AP213-01 MICROBORE WITH NON-VENTED SPIKE, 0.2μm FILTER AND NEEDLELESS Y-SITE — EITAN MEDICAL LTD
- AP214-01 - MICROBORE YELLOW MARKED WITH VENTED/NON VENTED SPIKE AND 0.2 FILTER — EITAN MEDICAL LTD
- AP214-01 MICROBORE YELLOW MARKED WITH VENTED/NON-VENTED SPIKE AND 0.2μ FILTER — EITAN MEDICAL LTD
- AP402-01 MICROBORE YELLOW MARKED WITH NON-VENTED SPIKE — EITAN MEDICAL LTD
- AP403-01 - MICROBORE WITH NON-VENTED SPIKE — EITAN MEDICAL LTD
- AP403-01 MICROBORE WITH NON-VENTED SPIKE — EITAN MEDICAL LTD
- AP409-01 - PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK — EITAN MEDICAL LTD
- AP414-01 MICROBORE WITH NON-VENTED SPIKE, FEMALE LUER LOCK WITH A BCV — EITAN MEDICAL LTD
- AP416-01 MICROBORE WITH 2 FEMALE LUER LOCKS AND A BACK CHECK VALVE — EITAN MEDICAL LTD
- AP424-01 - MICROBORE WITH NON-VENTED SPIKE, FEMALE LUER LOCK WITH A BACK CHECK V — EITAN MEDICAL LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Eitan Medical Ltd
Sources (1)
- FDA UDI 51c959d8-46b7-4db8-889f-a199e6fea371 36 fields · synced Jun 8, 2026